Valacyclovir (Page 8 of 8)

Principal Display Panel

NDC: 70934-106-14

Label
(click image for full-size original)
VALACYCLOVIR valacyclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-106(NDC:31722-704)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code I;86
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-106-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203047 04/16/2018
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-106)

Revised: 12/2019 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.